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Analysts are extremely encouraged by Phase 2 trial results for Relay Therapeutics’ PI3KA inhibitor in treating vascular malformations (VM), prompting the biotech to eye a potential path to accelerated approval.
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Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
Last month, Revolution Medicines’ RAS inhibitor doubled survival in a Phase 3 pancreatic cancer trial. On the biotech’s heels are Immuneering, Actuate Therapeutics, Erasca and more, looking to improve on that result with increased tolerability—and more time for patients.
The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
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Read our takes on the biggest stories happening in the industry.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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In 2022, Elon Musk’s Neuralink tried – and failed – to secure permission from the FDA to run a human trial of its implantable brain-computer interface, according to a report published Thursday.
MorphoSys AG announced Thursday it plans to drop its pre-clinical programs and cut 17% of its workforce in an effort to extend its cash runway.
Novo Nordisk announced Thursday it plans to expand its research and development operations in the greater Boston area and add over 200 new jobs this year.
Thymmune is backed by an A-list team of investors including Pillar VC, former Alnylam CEO John Maraganore and famed geneticist George Church.
Eli Lilly is expanding its pain management pipeline with a new asset from Belgium-based Confo Therapeutics targeting the angiotensin II type 2 receptor.
Backed by Google Ventures, ARCH Venture Partners and more, Chroma Medicine announced the closing of a $135 million Series B financing Wednesday.
Phase III KEYNOTE-671 study data showed Merck’s Keytruda improved event-free survival, one of the trial’s primary endpoints, in patients with stage II, IIIA or IIIB non-small cell lung cancer.
Novavax expressed doubts about its ability to continue operations beyond this year in its Q4 and full year 2022 financial report issued Tuesday.
Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.